Evidence map›Paper›PMID 34472042›Full record

ArticleCardiovascular engineering and technology2022

Simulating Radial Pressure Waveforms with a Mock Circulatory Flow Loop to Characterize Hemodynamic Monitoring Systems.

Anna Packy, Gavin A D'Souza, Masoud Farahmand, Luke Herbertson, Christopher G Scully

Open access · greenAbstract read
In one paragraph

Article in Cardiovascular engineering and technology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Anna PackyCenter for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Gavin A D'SouzaCenter for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Masoud FarahmandCenter for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Luke HerbertsonCenter for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Christopher G ScullyCenter for Devices and Radiological Health, Office of Science and Engineering Laboratories, U.S. Food and Drug Administration, Bldg. 62 Rm 1129, 10903 New Hampshire Ave., Silver Spring, MD, 20993, USA. Christopher.Scully@fda.hhs.gov.ORCID 0000-0001-8244-0832
United States Food and Drug Administration · US

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

purposeMock circulatory loops (MCLs) can reproducibly generate physiologically relevant pressures and flows for cardiovascular device testing. These systems have been extensively used to characterize the performance of therapeutic cardiac devices, but historically MCLs have had limited use for assessing patient monitoring systems. Here, we adapted an MCL to include peripheral components and evaluated its utility for qualitative and quantitative benchtop testing of hemodynamic monitoring devices.

methodsAn MCL was designed to simulate three physiological hemodynamic states: normovolemia, cardiogenic shock, and hyperdynamic circulation. The system was assessed for stability in pressure and flow values over time, repeatability, waveform morphology, and systemic-peripheral pressure relationships.

resultsFor each condition, cardiac output was controlled to the nearest 0.2 L/min, and flow rate and mean arterial pressure remained stable and repeatable over a 60-s period (n = 5, standard deviation of ± 0.1 L/min and ± 0.84 mmHg, respectively). Transfer function analyses showed that the systemic-peripheral relationships could be adequately manipulated. The results from this MCL were comparable to those from other published MCLs and computational simulations. However, resolving current limitations of the system would further improve its utility. Three pulse contour analysis algorithms were applied to the pressure and flow data from the MCL to demonstrate the potential role of MCLs in characterizing hemodynamic monitoring systems.

conclusionOverall, the development of robust analysis methods in conjunction with modified MCLs can expand device testing applications to hemodynamic monitoring systems. Properly validated MCLs can create a stable and reproducible environment for testing patient monitoring systems over their entire operating ranges prior to clinical use.

Indexed as

Heart-Assist DevicesHemodynamic MonitoringBlood PressureHemodynamicsHumansModels, CardiovascularMonitoring, PhysiologicRadial ArteryCardiac device testingCardiovascular flow circuitHemodynamic monitoring devicesPulse contour analysis

Identifiers

PMID34472042
PMCPMC8885788
OpenAlexW3196619114

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.